Device product
Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350
Z-0014-2020
Product summary
- Firm
- Inter-Med Llc
- Event
- Event 83435
- Status
- Terminated
- Classification
- Class II
- Quantity
- 768 units
- Official record key
device-enforcement:Z-0014-2020
Official wording
Reason: The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution.
Code information: UDI (01)10818207020458 Lot/Work Order Numbers: 20190197 20190723 20190834 20190862 20190952
Distribution pattern: US, South Africa, Switzerland, Poland, Italy, Singapore, Australia
Derived failure modes
-
Unknown
The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution.